Ibuprofen

Generic Name: ibuprofen (EYE bue PROE fen)

What is ibuprofen?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Ibuprofen is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.
Ibuprofen is used in adults and children who are at least 6 months old.

Important information

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen, especially in older adults.

Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or intestines. Use only the smallest amount of medication needed to get relief from your pain, swelling, or fever.

Before taking this medicine

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen, especially in older adults.
You should not use ibuprofen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a history of heart attack, stroke, or blood clot;
• a history of stomach ulcers or bleeding;
• asthma;
• liver or kidney disease;
• fluid retention; or
• a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, or lupus.
  
  
  
  Taking ibuprofen during the last 3 months of pregnancy may harm the unborn baby.Do not use this medicine without a doctor's advice if you are pregnant.
  
  It is not known whether ibuprofen passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.
  
  Do not give ibuprofen to a child younger than 2 years old without the advice of a doctor.
  A child's dose of ibuprofen is based on the age and weight of the child. Carefully follow the dosing instructions provided with your child's medicine for the age and weight of your child. Ask a doctor or pharmacist if you have questions.
  Take ibuprofen with food or milk to lessen stomach upset.
  Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
  The ibuprofen chewable tablet must be chewed before you swallow it.
  If you use this medicine long-term, you may need frequent medical tests.
  Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.
  Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
  
  

  Ibuprofen dosing information

  Usual Adult Dose for Dysmenorrhea:
  200 to 400 mg orally every 4 to 6 hours as needed.
  Usual Adult Dose for Osteoarthritis:
  Initial dose: 400 to 800 mg orally every 6 to 8 hours.
  Maintenance dose: May be increased to a maximum daily dose of 3200 mg based on patient response and tolerance.
  Usual Adult Dose for Rheumatoid Arthritis:
  Initial dose: 400 to 800 mg orally every 6 to 8 hours.
  Maintenance dose: May be increased to a maximum daily dose of 3200 mg based on patient response and tolerance.
  Usual Adult Dose for Headache:
  Study (n=34) - Prevention of Electroconvulsive therapy (ECT)-induced headache:
  600 mg orally 90 minutes prior to the initial ECT session
  Usual Adult Dose for Pain:
  Oral: Mild to moderate pain:
  200 to 400 mg orally every 4 to 6 hours as needed. Doses greater than 400 mg have not been proven to provide greater efficacy.
  
  IV: (Patients should be well hydrated before IV ibuprofen administration):
  Pain: 400 to 800 mg intravenously over 30 minutes every 6 hours as needed.
  Usual Adult Dose for Fever:
  Oral:
  200 to 400 mg orally every 4 to 6 hours as needed.
  
  IV: (Patients should be well hydrated before IV ibuprofen administration):
  Fever: Initial: 400 mg intravenously over 30 minutes
  Maintenance: 400 mg every 4 to 6 hours or 100 to 200 mg every 4 hours as needed.
  
  

  What happens if I overdose?

  Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.
  
  

  Ibuprofen side effects

  Get emergency medical help if you have signs of an allergic reaction to ibuprofen: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
  Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
  Stop using ibuprofen and call your doctor at once if you have:
  

  • changes in your vision;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • the first sign of any skin rash, no matter how mild;
  • signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
  • low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

  Common ibuprofen side effects may include:
  

  • upset stomach, mild heartburn, nausea, vomiting;
  • bloating, gas, diarrhea, constipation;
  • dizziness, headache, nervousness;
  • mild itching or rash; or
  • ringing in your ears.

  This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  
  
  
  
  

  Brand Name Contains Manufacturer IRUFEN 400  Ibuprofen 400mg/tablet Ziska Pharmaceuticals Ltd. NEOFLAM  Ibuprofen 400mg/tablet Aexim Pharmaceuticals Ltd. NEUROFEN  Ibuprofen 400mg/tablet Globe Pharmaceuticals Ltd. PEFLAM  Ibuprofen BP 100mg/5ml APC Pharmaceuticals Ltd. PROFEN  Ibuprofen 400mg/tablet Acme Laboratories Ltd. PROFEN  Ibuprofen BP 100mg/5ml Acme Laboratories Ltd. RAPOFEN  Ibuprofen 400mg/tablet Pharmadesh Laboratories Ltd. REBUFEN-400  Ibuprofen 400mg/tablet Rephco Laboratories Ltd. REBUPROFEN  Ibuprofen 400mg/tablet Renata Limited REUFEN  Ibuprofen 200mg & 400mg/tablet Gaco Pharmaceuticals REUFEN  Ibuprofen BP 100mg/5ml Gaco Pharmaceuticals REUMAFEN  Ibuprofen BP 100mg/5ml Beximco Pharmaceuticals Ltd. REUMAFEN  Ibuprofen 200mg & 400mg/tablet Beximco Pharmaceuticals Ltd. ROFLAM  Ibuprofen 400mg/tablet Rasa Pharmaceuticals Ltd SIFLAM  Ibuprofen 400mg/tablet Silva Pharmaceuticals Ltd. TRUFEN 400  Ibuprofen 400mg/tablet Modern Pharmaceuticals Ltd. TYFLAM 400  Ibuprofen 400mg/tablet Proteety Pharmaceuticals Ltd. UNIFLAM 400  Ibuprofen 400mg/tablet Bristol Pharma Ltd.
  Monitoring: -Neonates: Monitor renal function and urinary output during therapy. -Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy. -Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding. -Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion. -Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy. Patient advice: -Patients should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema. -Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body. -Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; this drug should not be used during pregnancy at 30 weeks gestation or later. -Patients should contact a healthcare provider if symptoms persist for more than 3 days in pediatric patients and more than 10 days in adult patients.
  References 1. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn, Kalamazoo, MI. 2. Cerner Multum, Inc. "Australian Product Information." O 0 3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 4. "Product Information. Caldolor (ibuprofen)." Cumberland Pharmaceuticals Inc, Nashville, TN. 5. "Product Information. NeoProfen (ibuprofen)." Ovation Pharmaceuticals Inc, Deerfield, IL. 6. "Product Information. Ibuprofen (ibuprofen)." Par Pharmaceutical Inc, Spring Valley, NY. Not all side effects for ibuprofen may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FD.